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CYP 2C19 Polymorphism and Voriconazole Trough Concentration in Chinese Adult Patients

NCT02100761 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2014-04-01

No results posted yet for this study

Summary

To investigate the relationship between cytochrome P450 (CYP) 2C19 genetic polymorphism and the steady-state blood concentration of voriconazole in Chinese patients with invasive pulmonary aspergillosis (IPA), and to assess the effects of voriconazole trough concentration on the prognosis of IPA patients.

Conditions

  • Invasive Pulmonary Aspergillosis

Interventions

DRUG

Voriconazole

Patients with creatinine clearance at least 50 ml/min will be treated with voriconazole by intravenous drip infusion at the dose of 6 mg/kg twice daily on the first day (Day 1) and 4 mg/kg twice daily from day 2 onward. The IV treatment is at least 7 days. Then switch to 200 mg orally twice daily between meals. The total treatment duration is at least 14 days Patients with creatinine clearance \<50 ml/min will be treated with oral voriconazole (loading dose of 400 mg twice daily followed by maintenance dose of 200 mg twice daily between meals for at least 14.0 days).

Sponsors & Collaborators

  • Shandong Provincial Hospital

    collaborator OTHER_GOV

  • Qianfoshan Hospital

    collaborator OTHER

  • Shandong thorax hospital

    collaborator UNKNOWN

  • Jinan Military General Hospital

    collaborator OTHER

  • Jinan Central Hospital

    collaborator OTHER

  • dingshifang

    lead OTHER

Principal Investigators

  • Shifang Ding, Ph.D. · Qilu Hospital of Shandong University

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02100761 on ClinicalTrials.gov